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The MINI LAP Pediatric Instruments with MEDUSA Clamping system are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues as well as items such as hernia mesh, during pediatric surgery.

The MNI LAP Pediatric Instruments with MEDUSA Clamping system are a family of minimally invasive devices intended for pediatric surgery. The devices penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues as well as items such as hernia mesh, during pediatric surgery.

Prior to insertion, the physician must depress the safety button and retract the instrument into the needle. The needle is inserted through the soft tissue under visualization. Once the needle has penetrated the soft tissue, the physician will advance the instrument into the body cavity using the handle. As the instrument advances, the jaws of the instrument will open. The instrument will be offered in various configurations including babook clamp, bowel clamp, and hernia clamp. The device includes a selfsching safety that prohibits the jaws from returning to their fully retracted position while in use, which acts as a blunt shield for the sharp needle tip.

The device is provided in the following configurations:

The devices are sterile disposable, single patient only. The devices were designed to hold pneumoperitoneum during use ..

The provided document is a 510(k) premarket notification for the MINI LAP Pediatric Instruments with Medusa Clamping System. This type of submission focuses on demonstrating substantial equivalence to pre-existing devices, rather than establishing a device's de novo effectiveness through extensive clinical trials with acceptance criteria and detailed performance studies typically associated with AI/software devices.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, device performance metrics, sample sizes for test/training sets, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

The document mainly provides:

• Device Description: A family of minimally invasive devices intended for pediatric surgery to grasp, hold, and manipulate soft internal tissues and hernia mesh.
• Indications for Use: The devices penetrate soft tissue to access certain areas of the human anatomy and are used to grasp, hold, and manipulate soft internal tissues and hernia mesh during pediatric surgery.
• Technological Characteristics: The manufacturer states the device is substantially equivalent to predicate devices.
• Performance Data: "The subject device has been subjected to and passed a variety of mechanical tests and evaluations. Additionally, the device is composed of biocompatible materials with a history of usage in the medical device industry." This is a high-level statement indicating testing was done, but no specific acceptance criteria or results are provided.
• Predicate Devices: A list of previously cleared devices to which the MINI LAP is compared for substantial equivalence.

Without further detailed study reports, it's impossible to fill out the requested table and answer the specific questions about acceptance criteria and study data.

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